Generic Name: sunitinib (soo-NI-ti-nib)
Brand Name: Sutent
Severe and sometimes fatal liver problems have occurred in patients who take Sutent. Contact your doctor immediately if you experience symptoms of liver problems, including dark urine, itching, loss of appetite, nausea, pale stools, stomach pain, unusual tiredness, or yellowing of the eyes or skin.
Sutent is used for:
Treating a certain type of stomach, bowel, or esophagus tumor in certain patients. It is also used to treat certain types of kidney or pancreatic cancer. It may also be used for other conditions as determined by your doctor.
Sutent is a multikinase inhibitor. It works by preventing the growth of cancer cells.
Do NOT use Sutent if:
- you are allergic to any ingredient in Sutent
- you have a history of abnormal liver function tests or liver problems caused by Sutent
- you are taking St. John's wort
Contact your doctor or health care provider right away if any of these apply to you.
Before using Sutent:
Some medical conditions may interact with Sutent. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney problems, liver problems, or muscle problems
- if you have a history of congestive heart failure, angina, irregular heartbeat (eg, QT prolongation), slow heartbeat, or other heart problems (eg, heart attack); a recent stroke or transient ischemic attack (TIA) (mini-stroke); a blood clot in the lung (pulmonary embolism); blood vessel problems or certain blood vessel surgery (coronary or peripheral artery bypass graft); diabetes; or high or low blood sugar; or if you are at risk of heart problems
- if you have bleeding problems, high blood pressure, blood electrolyte problems (eg, low blood magnesium or potassium levels), adrenal gland problems, thyroid problems, poor dental hygiene or other dental problems, or a seizure disorder (eg, epilepsy)
- if you have or have had pain in the mouth, teeth, or jaw; swelling or sores inside the mouth; numbness or a feeling of heaviness in the jaw; or loosening of a tooth
- if you have a severe infection, have recently been injured, or will be having surgery
- if you are on dialysis
- if you are taking a bisphosphonate (eg, alendronate, risedronate) or if you have taken one in the past
Some MEDICINES MAY INTERACT with Sutent. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for aches and pains, cancer, depression or other mental or mood problems, diabetes or high blood sugar, heartburn, hepatitis C infection, HIV infection, immune system suppression, infections, inflammation or swelling, irregular heartbeat or other heart problems, narcotic addiction, nausea and vomiting, seizures, Tourette syndrome), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with Sutent. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Sutent
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sutent may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Sutent:
Use Sutent as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Sutent comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sutent refilled.
- Take Sutent by mouth with or without food.
- Swallow Sutent whole. Do not open the capsules. Do not break, crush, or chew before swallowing.
- Do not eat grapefruit or drink grapefruit juice while you take Sutent.
- If you miss a dose of Sutent, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Tell your health care provider about any missed dose.
Ask your health care provider any questions you may have about how to use Sutent.
Important safety information:
- Sutent may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Sutent may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Contact your doctor if you have a wound that does not heal properly while you are taking Sutent.
- Diarrhea, nausea, stomach upset, and vomiting are common with Sutent. Ask your doctor or pharmacist for ways to decrease these effects if they occur.
- A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this drug. Call your doctor right away if you have signs like change in thinking clearly and with logic, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache. Talk with the doctor.
- Certain jawbone problems have been reported in patients taking Sutent. The risk may be greater in patients who have poor dental hygiene or other dental problems, or in those who are taking bisphosphonates (eg, alendronate). Talk to your doctor about having a dental exam before you start to take Sutent. Ask your doctor any questions you may have about dental treatment while you take Sutent.
- A serious and possibly fatal condition called tumor lysis syndrome (TLS) has occurred in certain patients taking Sutent. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
- High protein levels in the urine and kidney problems have happened with Sutent. Sometimes, these have been fatal. You will need to have your urine checked while taking Sutent. Call your doctor right away if you have symptoms of kidney problems (eg, not able to pass urine, change in the amount of urine passed, blood in the urine).
- Very bad skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have happened with Sutent. Sometimes, these have been fatal. These can also cause very bad health problems that may not go away. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Serious and sometimes fatal heart problems (eg, heart failure, heart attack) have happened with Sutent. Call your doctor right away if you have chest pain or pressure; irregular heartbeat; shortness of breath; sudden, unusual weight gain; or swelling in the arms or legs.
- Serious and sometimes fatal blood problems (eg, thrombotic thrombocytopenic purpura/hemolytic uremic syndrome [TTP/HUS]) have happened with Sutent in some people. Call your doctor right away if you have any bruising or bleeding; unusual tiredness or weakness; dark urine or yellow skin or eyes; pale skin; change in how much urine is passed; vision changes; one-sided weakness, trouble speaking or thinking, or change in balance; or fever.
- Serious and sometimes fatal bleeding has happened with Sutent. Discuss any questions or concerns with your doctor.
- Sutent may lower blood sugar levels. This may lead to fainting or the need to go to the hospital. Low blood sugar may make you anxious, sweaty, weak, dizzy, or drowsy. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. Tell your doctor right away if you have any of these symptoms.
- Check blood sugar as you have been told by your doctor.
- Proper dental care is important while you are taking Sutent. Brush and floss your teeth and visit the dentist regularly.
- Certain patients taking Sutent should avoid certain dental procedures if possible. Tell your doctor or dentist that you take Sutent before you receive any medical or dental care, emergency care, or surgery.
- Skin or hair discoloration may occur while you are taking Sutent. Contact your doctor with any questions or concerns.
- Women who may become pregnant should use an effective form of birth control while they take Sutent. If you have questions about effective birth control, talk with your doctor.
- Lab tests, including complete blood cell counts, blood electrolytes, blood pressure checks, thyroid function, liver function, and electrocardiograms (ECG) and other heart function tests (echocardiograms), may be performed while you take Sutent. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: Sutent may cause harm to the fetus. Do not become pregnant while you are taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Sutent while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Sutent.
Possible side effects of Sutent:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Arm or leg pain; back or joint pain; changes in taste; constipation; diarrhea; dizziness; dry, thick, or cracked skin; hair discoloration; headache; indigestion; mild loss of appetite or stomach pain; mouth or tongue swelling, soreness, or irritation; nausea; stomach upset; tiredness; trouble sleeping; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); arm, calf, or leg pain, redness, swelling, or tenderness; blistering or rash on the palms of the hands and soles of the feet; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent cough or sore throat; mental or mood changes (eg, decreased alertness, depression, irritability); muscle pain, tenderness, or weakness; numbness or tingling of the hands or feet; one-sided weakness; seizures; severe or persistent headache, dizziness, diarrhea, back pain, tiredness, or weakness; severe stomach pain or swelling; skin color changes, redness, warmth, or swelling; slurred speech; swelling or pain in the jaw; symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or that get bigger; any bleeding that is severe or that you cannot stop); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the eyes or skin); symptoms of thyroid and adrenal gland problems (eg, agitation; appetite changes; changes in menstrual period; excessive sweating; hair loss; increased sensitivity to hot or cold conditions; nervousness; sudden, unusual weight changes; tremors; unusual nausea, vomiting, or diarrhea; worsening tiredness); vision changes or vision loss.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Sutent:
Store Sutent at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sutent out of the reach of children and away from pets.
- If you have any questions about Sutent, please talk with your doctor, pharmacist, or other health care provider.
- Sutent is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Sutent or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sutent. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sutent. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Sutent.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.